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| ID | Type | Description | Link |
|---|---|---|---|
| RENACALL | Other Identifier | Alias Study Number |
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100 patients with metastatic and/or advanced renal cell carcinoma treated with sunitinib (Sutent) will be inclued and followed with standard care plus a call center
Principal assumption : the proportion of patients presenting with at least one grade 3 or 4 AE (whether related to sunitinib or not).
RENACALL is a prospective intermediate care study whose main aim is to evaluate the impact of a therapy management platform on the management of patients suffering from advanced/metastatic renal cell carcinoma and receiving first line treatment with Sutent®.
100 mRCC patients treated receiving first line Sutent® treatment shall be included in the study, and shall benefit both from conventional follow-up and from additional therapy management platform-based follow-up. Platform follow-up shall consist in regular phone calls to accompany patients in their real life home management of their treatment with sunitinib (prevention, advice and guidance of patients towards options)..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients | Metastatic and/or advanced renal cell carcinoma patients treated with sunitinib in first line and followed by standard care plus call center |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best supportive care | Other | BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least 1 Adverse Event (AE) of Grade 3 or 4 Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was death related to AE. | Baseline up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least 1 Sunitinib Dose Reduction | Number of participants treated with sunitinib having had at least 1 dose reduction relative to the initial dose are reported. | Baseline up to 6 months |
| Number of Participants Involved in at Least 1 Occasion For Each of the Reasons for a Sunitinib Dose Reduction |
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Inclusion Criteria:
Man or woman aged 18 or over;
Non-inclusion criteria
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The 100 metastatic and/or advanced patients of the study will come from the population of patients under the care of French renal cell carcinoma oncologists
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de la Timone | Marseille | Cedex 5 | 13335 | France | ||
| CHU Strasbourg |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Title | Description |
|---|---|---|
| FG000 | Call Center | Participants with advanced/metastatic renal cell carcinoma (a/mRCC) being treated first line with sunitinib (dose as per the recommendations in the summary or product characteristics [SmPC]) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 6, 2019 | Jul 25, 2019 |
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| call center | Other | Nurses from a call center will call the patients at regular time to help patients in the management of their cancer, with some dietetic advices, medical advices etc. |
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Number of participants treated with sunitinib having had at least 1 dose reduction relative to the initial dose according to the reasons for dose reductions are reported. |
| Baseline up to 6 months |
| Average Sunitinib Dose Reduction | Baseline up to 6 months |
| Number of Participants With at Least 1 Temporary Interruption of Sunitinib Treatment | Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor. | Baseline up to 6 months |
| Mean Duration (in Days) of Temporary Interruption to Sunitinib Treatment | Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor. | Baseline up to 6 months |
| Number of Participants Involved on at Least 1 Occasion for Each of the Reasons for a Sunitinib Temporary Treatment Interruption | Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor. Participants were counted in more than 1 category. | Baseline up to 6 months |
| Number of Participants Who Permanently Discontinued Sunitinib Treatment | Reason for permanent discontinuation of sunitinib treatment included: progressive disease, toxicity, participant's choice, doctor's choice and death of participant. | Baseline up to 6 months |
| Number of Participants Involved on At Least 1 Occasion for Each of the Reasons for a Permanent Sunitinib Treatment Discontinuation | Reason for permanent discontinuation of sunitinib treatment included: progressive disease, toxicity, participant's choice, doctor's choice and death of participant. | Baseline up to 6 months |
| Mean Duration of Sunitinib Treatment | Total mean duration (in months) of sunitinib treatment is reported in this outcome measure. | Baseline up to 6 months |
| Number of Participants Classified on the Basis of Number of Sunitinib Treatment Cycles | Last treatment cycle was declared by doctor either on the notified date to discontinue sunitinib or on the date of the last consultation if sunitinib treatment was not stopped | Baseline up to 6 months |
| Number of Participants With At Least 1 Unplanned Hospitalization | Number of participants with at least 1 unplanned hospitalizations either related or unrelated to sunitinib were reported. | Baseline up to 6 months |
| Number of Participants With At Least 1 Unplanned Consultation | Number of participants with at least 1 unplanned consultations either related or unrelated to sunitinib were reported. | Baseline up to 6 months |
| Number of Participants Who Were "Adherent" as Per 4- Item Morisky Medication Adherence Scale (MMAS-4) | MMAS-4 is a self-reported measure of medication taking behavior, consisting of 4 questions based on forgetting taking medication, carelessness about taking medication, stopping medication when feeling better, or stopping medication when feeling worse. Each question has answer either "Yes" or "No"; "Yes" =1 and "No" =0. The sum of answer to all 4 questions resulted in total MMAS-4 score. Total MMAS-4 score ranges from 0 (best adherence) to 4 (worst adherence), a low score representing improved adherence. Adherent participants were defined as participants with an MMAS-4 score of 0. | Baseline up to 6 months |
| Mean 4-Item Morisky Medication Adherence Scale (MMAS-4) Score | MMAS-4 is a self-reported measure of medication taking behavior, consisting of 4 questions based on forgetting taking medication, carelessness about taking medication, stopping medication when feeling better, or stopping medication when feeling worse. Each question has answer either "Yes" or "No"; "Yes" =1 and "No" =0. The sum of answer to all 4 questions resulted in total MMAS-4 score. Total MMAS-4 score ranges from 0 (best adherence) to 4 (worst adherence), a low score representing improved adherence. High adherence: score of 0, average adherence: score of 1 or 2, poor adherence: score of 3 or 4. | Baseline up to 6 months |
| Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Best Response | ORR used for the assessment of response to treatment. As per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: Complete response (CR) was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimetre [mm]). No new lesions. Partial response (PR) was defined as greater than or equal to (>=) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. | Baseline up to 6 months |
| Mean Scores for Each Dimension on the Participant's Satisfaction (With the Management By the Telephone Call Center) Questionnaire | Participants' satisfaction with call center was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 4 dimensions with total of 8 items. Dimensions were: 1) Satisfaction with advice: 3 item, 2) Satisfaction with care, 3) Satisfaction concerning the service: 3 items and 4) Overall satisfaction with support in management of sunitinib treatment: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion equivalent to score of +2, +1, 1, -2 and no score respectively. A score was calculated for each dimension by calculating the mean scores obtained for each item if at least 50% of the items for the dimension had been completed (and are not "no opinion"). Overall possible mean score range for each dimension was +2 to -2, where higher scores signified higher satisfaction. | At the end of the study (At Month 6) |
| Number of Participants Who Reported Themselves Being "Satisfied" or "Very Satisfied" With the Management By the Telephone Call Center | Participants' satisfaction with call center was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 4 dimensions with total of 8 items. Dimensions were: 1) Satisfaction concerning advice: have 3 item, 2) Satisfaction concerning management: 1 items, 3) Satisfaction concerning the service: 3 items and 4) Overall satisfaction with support in management of sunitinib treatment: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion. In this outcome measure number of participants who were either "Satisfied" or "Very Satisfied" for overall satisfaction were reported. | At the end of the study (At Month 6) |
| Mean Scores for Each Dimension on the Physician's Satisfaction (With the Management By the Telephone Call Center) Questionnaire | Physician's satisfaction with call center service for participants' follow-up was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 3 dimensions with total of 5 items. Dimensions were: 1) Satisfaction concerning advice: had 3 items, 2) Satisfaction concerning management: 1 items and 3) Overall satisfaction: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion equivalent to score of +2, +1, 1, -2 and no score respectively. A score was calculated for each dimension by calculating the mean scores obtained for each item if at least 50% of the items for the dimension have been completed (and are not "no opinion"). Overall possible mean score range for each dimension was +2 to -2, where higher scores signified higher satisfaction. | At the end of the study (At Month 6) |
| Number of Investigating Physicians Who Reported Themselves Being "Satisfied" or "Very Satisfied" With the Management By the Telephone Call Center | Physicians' satisfaction with call center service for participants' follow-up was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 3 dimensions with total of 5 item. Dimensions were: 1) Satisfaction concerning advice: had 3 items, 2) Satisfaction concerning management: 1 items and 3) Overall satisfaction: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion. In this outcome measure number of physicians who were either "Satisfied" or "Very Satisfied" for overall satisfaction were reported. | Baseline up to 6 months |
| Total Number of Calls (Planned and Unplanned) | 1 participant can call more than once during the study. | Baseline up to 6 months |
| Number of Participants Who Were Taking Sunitinib as Told to Call Center During the First Call | Participants were followed up for taking their medication and they were supposed to respond either "yes" or "no". In this outcome measure participants who responded "Yes" are reported. | First call made anytime from baseline up to 6 months |
| Number of Participants With Their Responses as "Yes" Against the Actions of Investigating Physicians, as Told to Call Center During the First Call | Actions of investigating doctors/physicians: did doctor clearly explained how to take treatment, were participants given documentation about treatment by doctor or medical team, did doctor explained how to manage any side effects due to treatment which could occur and were prescriptions or orders for supportive medical treatments given by doctor. Participants responded either "Yes" or "No". In this outcome measure participants who responded "Yes" to each action are reported. | First call made anytime from baseline up to 6 months |
| Number of Telephone Calls Describing Actions Taken by Call Center | In this outcome measure number of telephone calls against each action taken/or described by the call center to the participants are reported. Actions taken by the call center included: 1) Given advice about managing the treatment: a) advice about taking Sunitinib, b) advice about using the Sunitinib follow-up diary, c) reporting any AE; 2) Given general preventative advice: a) advice about taking preventative systemic treatments, b) lifestyle advice, c) food/dietetic advice, d) oro-dental hygiene advice; 3) Given specific preventative advice for a type of AE: a) prevention of skin toxicities, b) prevention of gastrointestinal disorders, c) prevention of cardiac disorders, d) prevention of infectious/inflammatory problems, e)other preventative advice; 4) Actions recommended to participant: a) do not forget the planned consultation with the oncologist, b) get the additional investigations requested performed. | Baseline up to 6 months |
| Number of Telephone Calls Where Participants Declared Adverse Events | In this outcome measure total number of telephone calls where participants declared of any AE are reported. Participants could call more than once to declare AE. | Baseline up to 6 months |
| Strasbourg |
| Cedex |
| 67091 |
| France |
| Centre Hospitalier d'Annecy | Annecy | 74011 | France |
| Centre Catalan Urologie Andrologie | Cabestany | 66330 | France |
| Centre hospitalier de Chambery | Chambéry | 73000 | France |
| Hopital prive La Louviere | Lille | 59042 | France |
| Clinique Claude Bernard Chimiotherapie Ambulatoire | Metz | 57000 | France |
| CRLC Val d'Aurelle | Montpellier | 34295 | France |
| Polyclinique Gentilly | Nancy | 54000 | France |
| Polyclinique de Gentilly Service Oncologie Médicale | Nancy | 54100 | France |
| CHI de Cornouailles - Oncologie hospitalisation | Quimper | 29107 | France |
| Hopital Jean BERNARD - Tours - 7eme etage | Valenciennes | 59300 | France |
| Centre Alexis Vautrin | Vandœuvre-lès-Nancy | 54511 | France |
| FG001 | Standard of Care | Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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Safety population included participants treated with Sunitinib.
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| ID | Title | Description |
|---|---|---|
| BG000 | Call Center | Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks. |
| BG001 | Standard of Care | Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
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| Primary | Number of Participants With at Least 1 Adverse Event (AE) of Grade 3 or 4 Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. The severity was graded by NCI CTCAE v.4.03. Grade 1 was mild AE. Grade 2 was moderate AE. Grade 3 was severe AE. Grade 4 was life-threatening consequences and urgent intervention AE. Grade 5 was death related to AE. | Safety population included participants treated with Sunitinib. | Posted | Count of Participants | Participants | Baseline up to 6 months |
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| Secondary | Number of Participants With at Least 1 Sunitinib Dose Reduction | Number of participants treated with sunitinib having had at least 1 dose reduction relative to the initial dose are reported. | Safety population included participants treated with Sunitinib. | Posted | Count of Participants | Participants | Baseline up to 6 months |
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| Secondary | Number of Participants Involved in at Least 1 Occasion For Each of the Reasons for a Sunitinib Dose Reduction | Number of participants treated with sunitinib having had at least 1 dose reduction relative to the initial dose according to the reasons for dose reductions are reported. | Safety population included participants treated with Sunitinib. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline up to 6 months |
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| Secondary | Average Sunitinib Dose Reduction | Safety population included participants treated with Sunitinib. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | milligram per day (mg/day) | Baseline up to 6 months |
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| Secondary | Number of Participants With at Least 1 Temporary Interruption of Sunitinib Treatment | Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor. | Safety population included participants treated with Sunitinib. | Posted | Count of Participants | Participants | Baseline up to 6 months |
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| Secondary | Mean Duration (in Days) of Temporary Interruption to Sunitinib Treatment | Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor. | Safety population included participants treated with Sunitinib. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | days | Baseline up to 6 months |
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| Secondary | Number of Participants Involved on at Least 1 Occasion for Each of the Reasons for a Sunitinib Temporary Treatment Interruption | Reason for temporary dose interruptions included: who had AEs that were intolerable, surgery, omission, doctor choice and any other reason judged by doctor. Participants were counted in more than 1 category. | Safety population included participants treated with Sunitinib. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline up to 6 months |
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| Secondary | Number of Participants Who Permanently Discontinued Sunitinib Treatment | Reason for permanent discontinuation of sunitinib treatment included: progressive disease, toxicity, participant's choice, doctor's choice and death of participant. | Safety population included participants treated with Sunitinib. | Posted | Count of Participants | Participants | Baseline up to 6 months |
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| Secondary | Number of Participants Involved on At Least 1 Occasion for Each of the Reasons for a Permanent Sunitinib Treatment Discontinuation | Reason for permanent discontinuation of sunitinib treatment included: progressive disease, toxicity, participant's choice, doctor's choice and death of participant. | Safety population included participants treated with Sunitinib. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline up to 6 months |
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| Secondary | Mean Duration of Sunitinib Treatment | Total mean duration (in months) of sunitinib treatment is reported in this outcome measure. | Safety population included participants treated with Sunitinib. | Posted | Mean | Standard Deviation | Months | Baseline up to 6 months |
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| Secondary | Number of Participants Classified on the Basis of Number of Sunitinib Treatment Cycles | Last treatment cycle was declared by doctor either on the notified date to discontinue sunitinib or on the date of the last consultation if sunitinib treatment was not stopped | Safety population included participants treated with Sunitinib. | Posted | Count of Participants | Participants | Baseline up to 6 months |
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| Secondary | Number of Participants With At Least 1 Unplanned Hospitalization | Number of participants with at least 1 unplanned hospitalizations either related or unrelated to sunitinib were reported. | Analysis population included participants who were treated with Sunitinib and had follow up by call center along with conventional method. Data was collected only for the reporting arm "call center" as per the planned analysis. | Posted | Count of Participants | Participants | Baseline up to 6 months |
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| Secondary | Number of Participants With At Least 1 Unplanned Consultation | Number of participants with at least 1 unplanned consultations either related or unrelated to sunitinib were reported. | Analysis population included included participants who were treated with sunitinib and had follow up by call center along with conventional method. Data was collected only for the reporting arm "call center" as per the planned analysis. | Posted | Count of Participants | Participants | Baseline up to 6 months |
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| Secondary | Number of Participants Who Were "Adherent" as Per 4- Item Morisky Medication Adherence Scale (MMAS-4) | MMAS-4 is a self-reported measure of medication taking behavior, consisting of 4 questions based on forgetting taking medication, carelessness about taking medication, stopping medication when feeling better, or stopping medication when feeling worse. Each question has answer either "Yes" or "No"; "Yes" =1 and "No" =0. The sum of answer to all 4 questions resulted in total MMAS-4 score. Total MMAS-4 score ranges from 0 (best adherence) to 4 (worst adherence), a low score representing improved adherence. Adherent participants were defined as participants with an MMAS-4 score of 0. | Safety population included participants treated with Sunitinib. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | Baseline up to 6 months |
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| Secondary | Mean 4-Item Morisky Medication Adherence Scale (MMAS-4) Score | MMAS-4 is a self-reported measure of medication taking behavior, consisting of 4 questions based on forgetting taking medication, carelessness about taking medication, stopping medication when feeling better, or stopping medication when feeling worse. Each question has answer either "Yes" or "No"; "Yes" =1 and "No" =0. The sum of answer to all 4 questions resulted in total MMAS-4 score. Total MMAS-4 score ranges from 0 (best adherence) to 4 (worst adherence), a low score representing improved adherence. High adherence: score of 0, average adherence: score of 1 or 2, poor adherence: score of 3 or 4. | Safety population included participants treated with Sunitinib. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on a scale | Baseline up to 6 months |
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| Secondary | Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Best Response | ORR used for the assessment of response to treatment. As per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: Complete response (CR) was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimetre [mm]). No new lesions. Partial response (PR) was defined as greater than or equal to (>=) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. | Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who had telephone calls with call center. Data was collected only for the reporting arm "call center" as per the planned analysis. | Posted | Number | Percentage of participants | Baseline up to 6 months |
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| Secondary | Mean Scores for Each Dimension on the Participant's Satisfaction (With the Management By the Telephone Call Center) Questionnaire | Participants' satisfaction with call center was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 4 dimensions with total of 8 items. Dimensions were: 1) Satisfaction with advice: 3 item, 2) Satisfaction with care, 3) Satisfaction concerning the service: 3 items and 4) Overall satisfaction with support in management of sunitinib treatment: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion equivalent to score of +2, +1, 1, -2 and no score respectively. A score was calculated for each dimension by calculating the mean scores obtained for each item if at least 50% of the items for the dimension had been completed (and are not "no opinion"). Overall possible mean score range for each dimension was +2 to -2, where higher scores signified higher satisfaction. | Analysis population: participants who were investigated by the doctors, who met study eligibility criteria, had received at least 1 dose of Sunitinib and were followed up by call center and completed a self-administered satisfaction questionnaire about management by call center. Here, 'Number analyzed' = participants evaluable for specified rows. | Posted | Mean | Standard Deviation | Units on a scale | At the end of the study (At Month 6) |
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| Secondary | Number of Participants Who Reported Themselves Being "Satisfied" or "Very Satisfied" With the Management By the Telephone Call Center | Participants' satisfaction with call center was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 4 dimensions with total of 8 items. Dimensions were: 1) Satisfaction concerning advice: have 3 item, 2) Satisfaction concerning management: 1 items, 3) Satisfaction concerning the service: 3 items and 4) Overall satisfaction with support in management of sunitinib treatment: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion. In this outcome measure number of participants who were either "Satisfied" or "Very Satisfied" for overall satisfaction were reported. | Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who were followed up by call center and completed a self-administered satisfaction questionnaire about management by call center. | Posted | Count of Participants | Participants | At the end of the study (At Month 6) |
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| Secondary | Mean Scores for Each Dimension on the Physician's Satisfaction (With the Management By the Telephone Call Center) Questionnaire | Physician's satisfaction with call center service for participants' follow-up was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 3 dimensions with total of 5 items. Dimensions were: 1) Satisfaction concerning advice: had 3 items, 2) Satisfaction concerning management: 1 items and 3) Overall satisfaction: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion equivalent to score of +2, +1, 1, -2 and no score respectively. A score was calculated for each dimension by calculating the mean scores obtained for each item if at least 50% of the items for the dimension have been completed (and are not "no opinion"). Overall possible mean score range for each dimension was +2 to -2, where higher scores signified higher satisfaction. | Analysis population included all investigating doctors/physicians who completed a satisfaction questionnaire to assess the management of follow-up of participants by the call center. For this outcome measure 'Participant' refers to 'investigating physician'. | Posted | Mean | Standard Deviation | Units on a scale | At the end of the study (At Month 6) |
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| Secondary | Number of Investigating Physicians Who Reported Themselves Being "Satisfied" or "Very Satisfied" With the Management By the Telephone Call Center | Physicians' satisfaction with call center service for participants' follow-up was assessed via the self-administered questionnaire completed at the end of the study. Questionnaire evaluated 3 dimensions with total of 5 item. Dimensions were: 1) Satisfaction concerning advice: had 3 items, 2) Satisfaction concerning management: 1 items and 3) Overall satisfaction: 1 item. Each item had 5 responses: very satisfied, satisfied, not very satisfied, not satisfied and no opinion. In this outcome measure number of physicians who were either "Satisfied" or "Very Satisfied" for overall satisfaction were reported. | Analysis population included all investigating doctors/physicians who completed a satisfaction questionnaire to assess the management of follow-up of participants by the call center. For this outcome measure 'Participant' refers to 'investigating physician' | Posted | Number | Physicians | Baseline up to 6 months |
|
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| Secondary | Total Number of Calls (Planned and Unplanned) | 1 participant can call more than once during the study. | Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who had telephone calls with call center. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | Calls | Baseline up to 6 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Were Taking Sunitinib as Told to Call Center During the First Call | Participants were followed up for taking their medication and they were supposed to respond either "yes" or "no". In this outcome measure participants who responded "Yes" are reported. | Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who had telephone calls with call center. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | First call made anytime from baseline up to 6 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Their Responses as "Yes" Against the Actions of Investigating Physicians, as Told to Call Center During the First Call | Actions of investigating doctors/physicians: did doctor clearly explained how to take treatment, were participants given documentation about treatment by doctor or medical team, did doctor explained how to manage any side effects due to treatment which could occur and were prescriptions or orders for supportive medical treatments given by doctor. Participants responded either "Yes" or "No". In this outcome measure participants who responded "Yes" to each action are reported. | Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who had telephone calls with call center. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | First call made anytime from baseline up to 6 months |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Telephone Calls Describing Actions Taken by Call Center | In this outcome measure number of telephone calls against each action taken/or described by the call center to the participants are reported. Actions taken by the call center included: 1) Given advice about managing the treatment: a) advice about taking Sunitinib, b) advice about using the Sunitinib follow-up diary, c) reporting any AE; 2) Given general preventative advice: a) advice about taking preventative systemic treatments, b) lifestyle advice, c) food/dietetic advice, d) oro-dental hygiene advice; 3) Given specific preventative advice for a type of AE: a) prevention of skin toxicities, b) prevention of gastrointestinal disorders, c) prevention of cardiac disorders, d) prevention of infectious/inflammatory problems, e)other preventative advice; 4) Actions recommended to participant: a) do not forget the planned consultation with the oncologist, b) get the additional investigations requested performed. | Analysis population included all participants who were investigated by the doctors, who met the study eligibility criteria, had received at least 1 dose of Sunitinib and who had telephone calls with call center. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | Telephone calls | Baseline up to 6 months | Telephone calls | Telephone calls |
| |||||||||||||||||||||||||||||
| Secondary | Number of Telephone Calls Where Participants Declared Adverse Events | In this outcome measure total number of telephone calls where participants declared of any AE are reported. Participants could call more than once to declare AE. | Call center full analysis set (FAS) population included all participants who were investigated by doctors, who met the study eligibility criteria and had received at least 1 dose of Sunitinib and were followed up by call center. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | Telephone calls | Baseline up to 6 months | Telephone calls | Telephone calls |
|
|
Baseline up to 6 months
Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Call Center | Participants with a/mRCC being treated first line with sunitinib (dose as per the recommendations in the SmPC) were followed up conventionally and by call center. Participants were conventionally monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. In addition, the follow-up consisted of regular phone calls by the call center nurses using a computer-assisted telephone interview system; participants received 5 calls on Week 1, 2, 3, 4 and 5 of each Cycle 1 and 2 of sunitinib treatment and 2 calls on Week 2 and 4 of each Cycle 3 and 4 of sunitinib treatment. Each cycle was of at least 6 weeks. | 2 | 42 | 12 | 42 | 42 | 42 |
| EG001 | Standard of Care | Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks. | 3 | 27 | 15 | 27 | 27 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Adrenal Insufficiency | Endocrine disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA v15 | Non-systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA v15 | Non-systematic Assessment |
| |
| General Symptom | General disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA v15 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v15 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA v15 | Non-systematic Assessment |
| |
| Anti-Platelet Antibody Positive | Investigations | MedDRA v15 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA v15 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Neoplasm Progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v15 | Non-systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Cerebral Haematoma | Nervous system disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Clonus | Nervous system disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Ischaemic Stroke | Nervous system disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Paralysis | Nervous system disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Sensorimotor Disorder | Nervous system disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v15 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Blood Disorder | Blood and lymphatic system disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Platelet Disorder | Blood and lymphatic system disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Endocrine Disorder | Endocrine disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Dark Circles Under Eyes | Eye disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Eyelid Oedema | Eye disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Lacrimation Increased | Eye disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Anal Inflammation | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Anorectal Disorder | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Aphthous Ulcer | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Gastrointestinal Disorder | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Gingival Pain | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Gingivitis | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Glossitis | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Glossodynia | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Lip Pain | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Oral Pain | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v15 | Non-systematic Assessment |
| |
| General Physical Health Deterioration | General disorders | MedDRA v15 | Non-systematic Assessment |
| |
| General Symptom | General disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Inflammation | General disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Mucosal Dryness | General disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Mucosal Inflammation | General disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Xerosis | General disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Hepatocellular Injury | Hepatobiliary disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA v15 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA v15 | Non-systematic Assessment |
| |
| Blood Albumin Abnormal | Injury, poisoning and procedural complications | MedDRA v15 | Non-systematic Assessment |
| |
| Blood Creatinine Increased | Injury, poisoning and procedural complications | MedDRA v15 | Non-systematic Assessment |
| |
| Blood Lactate Dehydrogenase | Injury, poisoning and procedural complications | MedDRA v15 | Non-systematic Assessment |
| |
| Blood Pressure Increased | Injury, poisoning and procedural complications | MedDRA v15 | Non-systematic Assessment |
| |
| Blood Thyroid Stimulating Hormone Decreased | Injury, poisoning and procedural complications | MedDRA v15 | Non-systematic Assessment |
| |
| Blood Thyroid Stimulating Hormone Increased | Injury, poisoning and procedural complications | MedDRA v15 | Non-systematic Assessment |
| |
| Liver Function Test Abnormal | Injury, poisoning and procedural complications | MedDRA v15 | Non-systematic Assessment |
| |
| Prothrombin Time Ratio | Injury, poisoning and procedural complications | MedDRA v15 | Non-systematic Assessment |
| |
| Weight Decreased | Injury, poisoning and procedural complications | MedDRA v15 | Non-systematic Assessment |
| |
| White Blood Cell Count Decreased | Injury, poisoning and procedural complications | MedDRA v15 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Neuropathy Peripheral | Nervous system disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Food Aversion | Psychiatric disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Balanitis | Reproductive system and breast disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Scrotal Erythema | Reproductive system and breast disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Nasal Obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Throat Irritation | Respiratory, thoracic and mediastinal disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Hair Colour Changes | Skin and subcutaneous tissue disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Palmar-Plantar Erythrodysaesthesia Syndrome | Skin and subcutaneous tissue disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Rash Erythematous | Skin and subcutaneous tissue disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Skin Chapped | Skin and subcutaneous tissue disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Skin Discolouration | Skin and subcutaneous tissue disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Skin Fissures | Skin and subcutaneous tissue disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Skin Irritation | Skin and subcutaneous tissue disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Skin Reaction | Skin and subcutaneous tissue disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Yellow Skin | Skin and subcutaneous tissue disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Tooth Extraction | Surgical and medical procedures | MedDRA v15 | Non-systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v15 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v15 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jul 21, 2017 | Jul 25, 2019 | Prot_001.pdf |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000070456 | Call Centers |
| ID | Term |
|---|---|
| D000072182 | Non-Medical Public and Private Facilities |
| D004632 | Emergency Medical Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided
|
|
| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| OG001 |
| Standard of Care |
Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks. |
|
|
| OG001 |
| Standard of Care |
Participants with a/mRCC being treated first line with sunitinib (dose as per SmPC) were followed by conventional standard care method. Participants were monitored at the end of Cycles 1, 2 and 4 of sunitinib treatment as routine consultation visit at the oncology care centers. Each cycle was of at least 6 weeks. |
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| Units |
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| Counts |
|---|
| Participants |
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| Participants |
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| Participants |
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| Telephone calls |
|
|